(161a) A Digital Twin for High-Altitude Shipping Simulation Ofpre-Filled Syringes

A Digital Twin is presented to simulate the effects of high-altitude shipment on the container closure integrity of pre-filled syringes. The Digital Twin is represented as a hybrid physics-based and data-based block diagram in Simulink^® that utilizes PID friction compensation to simulate the motion of the rubber stopper seal. The modeling framework is derived from a tribology perspective and friction subroutines are compared. Laser displacement datasets are applied to demonstrate the model training workflow with offline controller tuning. The results indicate that the Digital Twin achieves a successful compromise between accuracy and economy, demonstrating a clear advantage over traditional workflows. Overall, this approach demonstrates the value of advanced modeling and simulation tools by enabling rapid risk assessment of global distribution of pre-filled syringes.